The present invention, in some embodiments thereof, relates to a medical device and/or method for insertion into vessels (e.g., arteries, Eustachian tubes, fallopian tubes), and, more particularly, but not exclusively, to a device and/or method for providing stability and/or support for the distal tip of the device.
Angioplasty is the technique of mechanically widening a narrowed or obstructed blood vessel, typically as a result of atherosclerosis. Angioplasty has come to include all manner of vascular interventions typically performed in a minimally invasive or percutaneous method.
Angioplasty guidewires may be used to guide stent catheters, for example, drug coated stents and/or bioabsorbable scaffolds to keep the vessels open following the procedure and/or to stretch stenoses more open.
In the current art, an empty and collapsed balloon placed at a distal tip of a catheter. The catheter riding on the guide wire, known as a balloon catheter, is passed into the narrowed locations and then the balloon is inflated to a fixed size using water pressures some 75 to 500 times normal blood pressure (6 to 20 atmospheres). The balloon crushes the fatty deposits, opening up the blood vessel for improved flow, and the balloon is then collapsed and withdrawn.
An issue with the current art, is that the blood vessel is often totally occluded and quite seriously misshapen by the obstructions in the blood vessel. Insertion of a leading guidewire (e,g, 0.014″ and even thinner distal tip) is a mandatory step required in order to cross an obstructed coronary or peripheral vessel. Guidewire insertion is followed by balloon passage through the atherosclerotic lesion and subsequent dilatation. The guidewire takes a position within the lumen that defines a default/uncontrolled location of the distal tip (e.g. the site of least resistance) but this is not always the center of the lumen and/or the site of vessel occlusion needed for plaque penetration. Thus a balloon or micro-catheter led guidewire fails to be properly centered within the blood vessel.